Medical Device and Consumables Provider

Electroneurodiagnostic Electrodes and Accessories

Our company has successfully obtained the industry's first MDR certificate

Recently, Xi'an Friendship Medical has successfully passed the EU MDR CE certification

with its strict qualitymanagement system and strong technological research and

development capabilities, and has obtained the industry's first MDR certificate issued

by the German notified body TUV Rheinland. The successful application for the MDR CE certificate marks a new level of standardization, standardization, and scientificity in

enterprise management for Xi'an Friendship Medical; On the one hand, it proves the

company's own strength, and on the other hand, it is a spur and affirmation for the

company's future growth. This MDR certificate indicates that our company has met

international standards in integrating variousmanagement systems, and our company can continuously and stably provide customers with expected and satisfactory

qualified products, significantly improving our competitiveness in

neuroelectrophysiological monitoring electrodes.


The EU MDR regulation was issued in 2017and officially replaced the Medical Device

Directive 93/42/EEC (MDD) and theActive Implant Medical Device Directive 90/385/EEC (AIMDD) from May 26, 2020. Compared to the old regulations, MDR has put forward

stricter requirements in terms of regulatory strength, certification difficulty, product

quality and safety assessment, enterprise compliance, and technical value.


As a leading third-party certification andtesting institution worldwide, TUV Rheinland

has considerable authority, professionalism, and high industry recognition. The   issuance of the MDRcertificate this time will effectively increase the market share   of Xi'an FriendshipMedical's leading products in the international market, and help

China's competitiveness and influence of medical devices in the international market.


In the future, facing new challenges andopportunities, we will be more down-to-earth, steady in our steps, and firm inour beliefs. We will continuously optimize and

standardize various management systems, improve the effectiveness of system

operation, and improve themanagement level of the company. Together, we will

promote the stable development of the company, speak the unchanging truth with

actions, and prove our strength with fruitful results!

MDR.jpg


互联网药品信息服务资格证书编号:(陕)-非经营性-2022-0017